DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group 1 (Claims 1-9) and Species A (Claims 5 and 14) in the reply filed on 08/07/2025 is acknowledged.
Claims 6 and 10-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/07/2025.
*Therefore, claims 1-5 and 7-9 are herein examined.
Priority
This application makes reference to or appears to claim subject matter disclosed in Application No. 63/293,559, filed 12/23/2021. If applicant desires to claim the benefit of a prior-filed application under 35 U.S.C. 119(e), 120, 121, 365(c) or 386(c), the instant application must contain, or be amended to contain, a specific reference to the prior-filed application in compliance with 37 CFR 1.78. If the application was filed before September 16, 2012, the specific reference must be included in the first sentence(s) of the specification following the title or in an application data sheet (ADS) in compliance with pre-AIA 37 CFR 1.76; if the application was filed on or after September 16, 2012, the specific reference must be included in an ADS in compliance with 37 CFR 1.76. For benefit claims under 35 U.S.C. 120, 121, 365(c), or 386(c), the reference must include the relationship (i.e., continuation, divisional, or continuation-in-part) of the applications.
If the instant application is a utility or plant application filed under 35 U.S.C. 111(a), the specific reference must be submitted during the pendency of the application and within the later of four months from the actual filing date of the application or sixteen months from the filing date of the prior application. If the application is a national stage application under 35 U.S.C. 371, the specific reference must be submitted during the pendency of the application and within the later of four months from the date on which the national stage commenced under 35 U.S.C. 371(b) or (f), four months from the date of the initial submission under 35 U.S.C. 371 to enter the national stage, or sixteen months from the filing date of the prior application. See 37 CFR 1.78(a)(4) for benefit claims under 35 U.S.C. 119(e) and 37 CFR 1.78(d)(3) for benefit claims under 35 U.S.C. 120, 121, 365(c), or 386(c). This time period is not extendable and a failure to submit the reference required by 35 U.S.C. 119(e) and/or 120, where applicable, within this time period is considered a waiver of any benefit of such prior application(s) under 35 U.S.C. 119(e), 120, 121, 365(c), and 386(c). A benefit claim filed after the required time period may be accepted if it is accompanied by a grantable petition to accept an unintentionally delayed benefit claim under 35 U.S.C. 119(e) (see 37 CFR 1.78(c)) or under 35 U.S.C. 120, 121, 365(c), or 386(c) (see 37 CFR 1.78(e)). The petition must be accompanied by (1) the reference required by 35 U.S.C. 120 or 119(e) and by 37 CFR 1.78 to the prior application (unless previously submitted), (2) the applicable petition fee under 37 CFR 1.17(m)(1) or (2), and (3) a statement that the entire delay between the date the benefit claim was due under 37 CFR 1.78 and the date the claim was filed was unintentional. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application. The Director may require additional information where there is a question whether the delay was unintentional. The petition should be addressed to: Mail Stop Petition, Commissioner for Patents, P.O. Box 1450, Alexandria, Virginia 22313-1450.
If the reference to the prior application was previously submitted within the time period set forth in 37 CFR 1.78 but was not included in the location in the application required by the rule (e.g., if the reference was submitted in an oath or declaration or the application transmittal letter), and the information concerning the benefit claim was recognized by the Office as shown by its inclusion on the first filing receipt, the petition under 37 CFR 1.78 and the petition fee under 37 CFR 1.17(m)(1) or (2) are not required. Applicant is still required to submit the reference in compliance with 37 CFR 1.78 by filing an ADS in compliance with 37 CFR 1.76 with the reference (or, if the application was filed before September 16, 2012, by filing either an amendment to the first sentence(s) of the specification or an ADS in compliance with pre-AIA 37 CFR 1.76). See MPEP § 211.02.
More information regarding unintentionally delayed domestic benefit claims can be found at https://www.uspto.gov/patents/apply/petitions/13-unintentionally-delayed-domestic-benefit-claims.
Specification
The disclosure is objected to because of the following informalities:
Page 2, lines 3-4: “cause antimicrobial effects in or in the body” should be changed to “cause antimicrobial effects in or on the body”.
Page 5, line 6: “The second portion’s interior acting as a beam forming element” should be changed to “The second portion’s interior acts as a beam forming element”
Page 5, line 21: “to provide consisted dosing” should be changed to “to provide consistent dosing”.
Page 7, lines 5-6: “the diameter of the first portion 21 and diameter of the second portion 22 may be of different” should be changed to “the diameter of the first portion 21 and diameter of the second portion 22 may be different”. Please remove “of”.
Page 7, line 14: “source. 10” should be changed to “source 10”. Please remove period (“.”) after “source”.
Page 7, line 18: “treatment, proves” should be changed to “treatment, which proves”.
Page 8, line 13: “paired with a calibrated bodies 20” should be changed to “paired with calibrated bodies 20”. Please remove “a”.
Page 8, line 13: “produce standardize dose rates” should be changed to “produce standardized dose rates”.
Appropriate correction is required.
Claim Interpretation
The term “comfortable levels” in claim 9 is considered a relative term. However, the instant specification (in the paragraph spanning pages 2-3) explains that “Intensities exceeding 100 mW/cm2 can cause discomfort when shined into a wound, comfort threshold as discussed herein means under 100 mW/cm2”. Therefore, the phrase “exceeding comfortable levels” in claim 9 is interpreted to mean exceeding 100 mW/cm2.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 4-5, and 9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites the limitation "the treatment space" in line 2. There is insufficient antecedent basis for this limitation in the claim. Please consider changing to “a treatment space”.
Claim 4 recites the limitation "the visible or ultraviolet wavelengths" in line 2. There is insufficient antecedent basis for this limitation in the claim. Please consider removing “the” before “visible or ultraviolet wavelengths”.
The limitation “re-emit in visible wavelengths” renders claim 4 (line 3) indefinite. It is unclear whether these are the same or different visible wavelengths that are being absorbed earlier in claim 4 (line 2). In other words, are the photoluminescent materials absorbing visible wavelengths of light and then re-emitting the same visible wavelengths? In this case, would the photoluminescent materials be considered as reflecting visible wavelengths? If so, consider changing the limitation to “re-emit in the visible wavelengths”. Or, are the visible wavelengths being re-emitted by the photoluminescent materials different than the visible wavelengths being absorbed by the photoluminescent materials? Based on the Applicant’s specification (2nd Paragraph of page 7), it appears that the photoluminescent materials absorb visible and UV light from inside the second portion 22 and then emit visible light outside of the second portion to serve as an indicator (i.e., visual que) to the user that the body 20 should be replaced. It is believed that the “re-emitted” visible light should not be interpreted as the visible light being reflected. However, this is not specifically clear based on the claim language alone. One suggestion would be distinguishing the visible wavelengths being absorbed by the photoluminescent materials as being “first” visible wavelengths and the visible wavelengths being re-emitted by the photoluminescent materials as being “second” visible wavelengths. It is believed that this suggestion would prevent the question of whether the visible wavelengths being absorbed and re-emitted are the same or different. This is just a suggestion and not necessarily the only or best way to provide further clarity for this claim. Please provide further clarification and consider revising this claim to ensure that the claim is being conveyed as intended.
Claim 5 recites the limitation "said body’s interior" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Please consider changing this limitation to “an interior of said body”
Claim 5 recites the limitation “intensity of said treatment spot” in line 3, whereas a calibrated intensity was already introduced in a claim that claim 5 depends from (claim 1, line 8). It is unclear whether the Applicant intended for this “intensity of said treatment spot” to refer to (i.e., be the same as) the calibrated intensity introduced in claim 1. Consider changing to “the intensity of said treatment spot” or “the calibrated intensity of said treatment spot”.
Claim 5 recites the limitation "said source beam intensity" in line 3. There is insufficient antecedent basis for this limitation in the claim. Please consider changing to “a source beam intensity”.
Claim 9 recites the limitation "said second portion length" in line 1. There is insufficient antecedent basis for this limitation in the claim. Please consider changing to “a length of said second portion”.
Claim 9 recites the limitation “intensity” in line 2, whereas a calibrated intensity was already introduced in a claim that claim 9 depends from (claim 1, line 8). It is unclear whether the Applicant intended to claim the same or a different intensity. Consider changing to “the intensity” or “the calibrated intensity”.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5, and 7-9 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Silver, et al. (U.S. PGPub No. 2021/0322782). Avci, et al. (“Low-level laser (light) therapy (LLLT) in skin: stimulating, healing, restoring” – see attached) is relied upon as evidence for claim 9.
Regarding claim 1, Silver teaches (Figs. 1-3, # 10 – light emitting apparatus, i.e. phototherapy system) a phototherapy system for delivering a calibrated dose of light (Abstract – emitting therapeutic light to treat biological tissue, i.e. phototherapy; Par. [0002]; Par. [0105]), comprising:
(Fig. 4, # 18 – light source, 12/12’ – body (the body’s end portions surrounding light source considered a cylindrical bezel end) – see also annotated Fig. 4 below) a light source configured to project a source beam from a cylindrical bezel end (Par. [0105-0106] – Apparatus 10 includes a light source 18 supported at distal end portions of the body 12 and 12’);
(Fig. 4, # 6 – shroud, i.e. cylindrical body – see also annotated Fig. 4 below) a beam forming cylindrical body constructed with open ends having a first portion and a second portion (Par. [0105]; Par. [0107] – Shroud 6 is dimensioned and configured to establish an effective distance and area of therapeutic treatment relative to the biological tissue 2 to be treated);
(Figs. 4-7, # 6 – shroud, i.e. includes first portion, 12/12’ – body, i.e. includes bezel end – see also annotated Fig. 4 below) said first portion arranged to slidingly engage over said bezel end to sealingly fill said first portion while leaving said second portion empty (Par. [0107] – Holding pins 14 are inserted into shroud pin opening 28 and body pin opening to attach shroud 6 to body portions 12 and 12’ – It is noted that it is shown particularly in Figs. 4 and 6 that the shroud 6 is slid over the body portions 12 and 12’); and
(Fig. 1, # 4; Fig. 4, # 6 – shroud, i.e. includes second portion – see annotated Fig. 4 below) said second portion aligned to pass a majority of said source beam such that a contained treatment spot of calibrated intensity projects from said open end of said second portion (Par. [0105] – Therapeutic light emitting apparatus 10 is adapted and configured for performing biological tissue therapy on light treatment area 4 of biological tissue 2 of patient; Par. [0107] – Shroud 6 is dimensioned and configured to establish an effective distance and area of therapeutic treatment relative to the biological tissue 2 to be treated. Shroud can be formed from a material that is impervious to therapeutic light so as to avoid an impact of therapeutic light on areas of biological tissue 2 that are not intended to be treated – this is representative of a contained treatment spot of calibrated intensity that projects from the open end of the second portion).
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Annotated Fig. 4
Therefore, claim 1 is unpatentable over Silver, et al.
Regarding claim 2, Silver teaches the apparatus of claim 1, wherein (Fig. 4, # 6 – shroud, i.e. body) said body is constructed of light blocking materials to prevent stray light from escaping into the treatment space (Par. [0107] – Shroud 6 can be formed from a material that is impervious to therapeutic light (such as irradiated acrylic) so as to avoid an impact of therapeutic light on areas of biological tissue 2 that are not intended to be treated; Par. [0111] – shroud can also be formed from amber colored plastic).
Therefore, claim 2 is unpatentable over Silver, et al.
Regarding claim 3, Silver teaches the apparatus of claim 1, wherein (Fig. 4, # 6 – shroud, i.e., includes second portion) said second portion is constructed of materials that reflect, absorb, and diffuse said source beam resulting in a more homogenized treatment spot (Par. [0107] – shroud 6 is dimensioned and configured to establish an effective distance and area of therapeutic treatment relative to the biological tissue 2 to be treated (i.e., more homogenized treatment spot). Shroud can be formed from a material that is impervious to therapeutic light (such as irradiated acrylic) so as to avoid impact of therapeutic light on areas of biological tissue 2 that are not intended to be treated – this is representative of the shroud reflecting, absorbing, and diffusing said source beam; Par. [0111] – shroud could be an amber colored plastic, that again is used as a material that is impervious to therapeutic light. Amber colored plastic would be known to one of ordinary skill in the art of also being able to reflect, absorb, and diffuse different wavelengths of the source beam).
Therefore, claim 3 is unpatentable over Silver, et al.
Regarding claim 5, Silver teaches the apparatus of claim 1, wherein said body is constructed and arranged such that said body's interior is reflective to spectra between 365nm to 470nm thereby increasing intensity of said treatment spot over said source beam intensity (Par. [0013] – the therapeutic light can be selected from the group of light sources that consists of UV light and low level laser light (i.e., would overlap with 365nm to 470nm wavelength range); Par. [0107] – shroud made of material that is imperious to (i.e., reflects) therapeutic light (such as irradiated acrylic) so as to avoid an impact of therapeutic light one areas of biological tissue that are not intended to be treated (i.e., increases intensity of treatment spot); Par. [0111] – shroud can also be made of amber-colored plastic).
Therefore, claim 5 is unpatentable over Silver, et al.
Regarding claim 7, Silver teaches the apparatus of claim 1, wherein (Fig. 4, # 12/12’ – body, i.e. makes up bezel end, 18 – light source) said bezel end further comprises a diameter equating to a standardized source beam output operable for universal dose time calibration when used with said body (Par. [0105-0106] – bezel end (i.e. distal part of body 12/12’) has a diameter equating to source beam output of light source 18. – Note: For the purposes of examination, Applicant is reminded that this is a product claim. Intended use/functional language does not require that reference specifically teach the intended use of the element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.).
Therefore, claim 7 is unpatentable over Silver, et al.
Regarding claim 8, Silver teaches the apparatus of claim 1, wherein (Fig. 4, # 6 and “DIA D1”) said body further comprises an interior diameter equating to a standardized second portion length operable for universal gauging of working distance for uniform dose times (Par. [0107] – Shroud 6 (i.e., body) is dimensioned and configured to establish an effective distance and area of therapeutic treatment relative to the biological tissue 2 to be treated. – Note: For the purposes of examination, Applicant is reminded that this is a product claim. Intended use/functional language does not require that reference specifically teach the intended use of the element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.).
Therefore, claim 8 is unpatentable over Silver, et al.
Regarding claim 9, Silver teaches the apparatus of claim 1, wherein (Fig. 4, # 6 and “DIA D1”) said second portion length is arranged to physically limit intensity of said treatment spot from exceeding comfortable levels (Par. [0007-0008] – novel directing of the light shown in this disclosure (via shrouds) enable the prevention of potential harmful radiation from injuring a patient (i.e., harmful levels/exceeding comfortable levels); Par. [0009] – increasing distance from the site decreases the effectiveness; Par. [0012] – by using more targeted and intermittent therapies, the surgeon is able to more precisely target tissue and wound sites and prevent overexposure to non-injured or injured tissue; Par. [0107] – Shroud 6 (i.e., body) is dimensioned and configured to establish an effective distance and area of therapeutic treatment relative to the biological tissue 2 to be treated.; - It is noted in Avci, et al. (“Low-level laser (light) therapy (LLLT) in skin: stimulating, healing, restoring”) that power densities < 100 mw/cm2 is considered normal (i.e., comfortable/not harmful) for phototherapy for treating the skin (see section titled “Low-Level Laser (Light) Therapy and Its Mechanism of Action”)).
Therefore, claim 9 is unpatentable over Silver, et al.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Silver, et al. (U.S. PGPub No. 2021/0322782) in view of Brown, et al. (U.S. PGPub No. 2019/0083177).
Regarding claim 4, Silver teaches the apparatus of claim 1, as indicated hereinabove. Silver does not explicitly teach the limitation of instant claim 4, that is wherein at least said second portion is constructed of photoluminescent materials that absorb light in the visible or ultraviolet wavelengths and then re-emit in visible wavelengths.
Brown is directed to analogous art and teaches that a distal end of an optical fiber may be protected by a variety of alternative protective caps, tips, and/or sleeves (Abstract; Par. [0002-0003]). Brown also teaches the limitation of instant claim 4, that is wherein (Figs. 7A-7C, # 32/32’; Figs. 10A-B, # 89) at least said second portion is constructed of photoluminescent materials that absorb light in the visible or ultraviolet wavelengths and then re-emit in visible wavelengths (Par. [0077] – those skilled in the art would appreciate that the soft protective tips 32, 32’, and/or plug 35 ma be doped with phosphors that emit radiation when laser energy is incident on the inner diameter of the soft protective tip. Such emission would indicate that the tip of the fiber was eroded and needs to be replaced. When the fiber tip 95 erodes too far into the soft tip, then the aiming beam will be deflected by the eroded surfaces to be incident on and excite phosphors 89 in the soft tip, resulting in emissions by the phosphors that can be detected at the proximal end of the fiber to provide an indication of the erosion).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented the photoluminescent materials of Brown’s protective caps, tips, and/or sleeves surrounding the distal end of an optical fiber into the shroud of Silver’s therapeutic lighting device because doing so would be an example of using a known technique to improve similar devices in the same way. One of ordinary skill in the art would have desired implementing Brown’s phosphors (i.e., photoluminescent material) into Silver’s second portion of the shroud in order to provide an indication that light from the light source is overly-incident on the second portion and a component of the device needs to be replaced (see Par. [0077] of Brown). One of ordinary skill in the art would have also looked to Brown’s teaching for alternative materials for the shroud since Silver broadly discloses using a material that is impervious to therapeutic light and gives examples of irradiated acrylic and amber colored plastic (see Par. [0107] and [0111] of Silver).
Therefore, claim 4 is unpatentable in view of Silver, et al. and Brown, et al.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Tapper, et al. (U.S. PGPub No. 2016/0045758) – see Figs. 19-20
Parel, et al. (U.S. PGPub No. 2023/0218923) – see Fig. 3A
Bean, et al. (U.S. PGPub No. 2011/0040358)
Beckman, et al. (U.S. PGPub No. 2015/0112411)
Piergallini, et al. (U.S. PGPub No. 2018/0071066)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL TAYLOR HOLTZCLAW whose telephone number is (571)272-6626. The examiner can normally be reached Monday-Friday (7:30 a.m.-5:00 p.m. EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL T. HOLTZCLAW/Examiner, Art Unit 3796